Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary and Secondary Ventral Hernia
Intervention: Placing the resorbable mesh (Procedure); Non-resorbable synthetic mesh. (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s): Frederik Berrevoet, MD, PhD, Principal Investigator, Affiliation: Ghent University Hospital
Overall contact: Frederik Berrevoet, MD, PhD, Email: Frederik.Berrevoet@ugent.be
Summary
Since abdominal wall hernia repair is currently performed with the use of a mesh, side
effects associated with the mesh are frequently reported during long term follow-up. These
side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and
inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing
mesh has been developed, which provides sufficient support and strength to allow efficient
recovery of the abdominal wall, but also disappear from your body in three years time, so
that you no longer have any synthetic material in your body. Previous resorbing meshes also
disappeared but over a much shorter period of time, so that the hernia was insufficiently
healed, with recurrence as a result.
The TIGRâ„¢ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh,
made of two commonly used polymers, however it will retain 50% of its initial strength after
six months. This in theory is enough to provide support of the collagen healing process
during the initial wound-healing phase, but also to support the transition of initial
collagen to functional collagen.
The aim of this study is to compare TIGRâ„¢ with large pore mesh used in the repair of the
anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias
are not part of the study).
Therefore the patients will be divided into two groups, one group will be treated with a
resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will
be no difference in the medication or the surgical techniques used.
Clinical Details
Official title: Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Recurrence rate at 3 years post-surgery.
Secondary outcome: Wound Morbidity 4 weeks post-surgery.Pain and discomfort after 1 year post-surgery. Pain and discomfort after 3 years post-surgery. Recurrence rate by clinical examination 1 year post-surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Primary and secondary ventral hernia
- less than 20 cm in length
- less than 6 cm in width
Exclusion Criteria:
Locations and Contacts
Frederik Berrevoet, MD, PhD, Email: Frederik.Berrevoet@ugent.be
Ghent University Hospital, Ghent 9000, Belgium; Recruiting Frederik Berrevoet, MD, PhD, Phone: +32(0)93324892, Email: Frederik.Berrevoet@ugent.be Frederik Berrevoet, MD, PhD, Principal Investigator
University Hospital Leuven, Leuven 3000, Belgium; Recruiting Marc Miserez, MD, PhD, Email: Marc.miserez@uzleuven.be Marc Miserez, MD, PhD, Principal Investigator
University of Copenhagen, Copenhagen DK-2400, Denmark; Recruiting Lars Nannestad Jorgensen, MD, DrMSc, Email: Larsnjorgensen@hotmail.com Lars Nannestad Jorgensen, MD, DrMSc, Principal Investigator
ul Jagalskiego, Wejherowo 84-200, Poland; Recruiting Maciej Smietanski, MD, PhD, Email: smietanski@herniaweb.org Maciej Smietanski, MD, PhD, Principal Investigator
Hospital de 12 Octobre, Madrid, Spain; Recruiting Maria Teresa Butron Vila, MD Maria Teresa Butron Vila, MD, Principal Investigator
Royal Infirmary of Edinburgh, Edinburgh EH16 4SA, United Kingdom; Recruiting Andrew de Beaux, MD FRCS MBcChB, Email: Andrew.Debeaux@luht.scot.nhs.uk Andrew de Beaux, MD FRCS MBChB, Principal Investigator
Additional Information
Starting date: February 2013
Last updated: December 4, 2014
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